HHS In role
Karim Mikhail
Director, FDA Center for Biologics Evaluation and Research (CBER)
Pharmacist (B.Pharm., M.Sc.) made permanent director of the FDA's Center for Biologics Evaluation and Research on September 8, 2026, after serving as acting director since spring 2026. He is Vinay Prasad's ultimate successor and owns biologics approvals and the vaccine-safety-surveillance overhaul.
Role status — October 2026: Mikhail is the permanent director of the FDA’s Center for Biologics Evaluation and Research (CBER), confirmed in the job on September 8, 2026 after serving as acting director from about May/June 2026.
Mikhail (B.Pharm., M.Sc.) is Vinay Prasad’s ultimate successor at CBER. The line ran from Prasad to acting director Katherine Szarama, who took over May 1, 2026, and then to Mikhail — first in an acting capacity, then permanently in September 2026.
CBER is the FDA center that owns biologics: vaccines, cell and gene therapies, and blood products. Under Mikhail that means both the approvals pipeline for those products and the vaccine-safety-surveillance overhaul, one of the most contested files in the Kennedy-era FDA.
Why tracked here: Mikhail now holds the biologics chair that Prasad made famous — every vaccine approval and safety-surveillance decision at FDA runs through his center.
Sources (Oct 2026): BioPharma Dive, Sept. 9, 2026; Becker’s Hospital Review (on the Szarama interregnum).